A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

Abbott432 enrolled

Overview

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

432

Conditions

Leiomyoma Menorrhagia Metrorrhagia

Interventions

AsoprisnilDRUG

10mg Tablet, oral Daily for 12 months

AsoprisnilDRUG

25 mg Tablet, oral Daily for 12 months

PlaceboDRUG

Tablet, oral Daily for 12 months

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Premenopausal women * History of regular menstrual cycles (21-42 days) * Diagnosis of uterine fibroid(s) * Abnormal vaginal bleeding associated with uterine fibroids * Otherwise in good health * Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails * Negative pregnancy test * Agrees to Double-barrier method of contraception * Pap smear with no evidence of malignancy or pre-malignant changes * Endometrial biopsy with no significant histological disorder Exclusion Criteria: * Any abnormal lab or procedure result the study-doctor considers important * Severe reaction(s) to or are currently using any hormone therapy * History of osteoporosis or other bone disease * Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months * History of Polycystic Ovary Syndrome or prolactinoma * MRI shows significant gynecologic disorder * Uterine size \> 25 weeks gestation * Hemoglobin \< 8 g/dL at Day -1

Outcomes

Primary Outcomes

The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.

Time frame: Month 12 or Final Visit

Secondary Outcomes

Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.

Time frame: Month 6

Change from baseline in menstrual pictogram score.

Time frame: Final Month

Change from baseline in number of days with bleeding.

Time frame: Final Month

Change from baseline in hemoglobin concentration.

Time frame: Final Visit

Percent change from baseline in volume of the largest fibroid.

Time frame: Final Visit

Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.

Time frame: Final Visit

Change from baseline in total symptom severity score and UFS-QOL total score.

Time frame: Final Visit

Cumulative percent of subjects who achieve amenorrhea.

Time frame: Month 3

Data from ClinicalTrials.gov

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